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The FDA said it won’t enforce former Federal Food, Drug and Cosmetic Act (FD&C) requirements for certain medical device data systems (MDDS), medical image storage devices or medical image communication devices, in a final guidance released yesterday. Read More
In comments on the third installment of the FDA’s draft guidance on patient-focused drug development, AdvaMed has recommended that the guidance not apply to medical devices — although the industry association says it supports the overall use of patient experience measures as clinical trial endpoints. Read More
The version of FDA user fee legislation that’s slated to get attached to a continuing resolution (CR) later this week — just days before the end of the agency’s fiscal year — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Read More
The FDA clarifies its regulatory approach to clinical decision support (CDS) software and gives examples of what it considers non-device CDS software in a final guidance published yesterday. Read More